[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518226":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":39,"locations":45,"responsibleParty":444,"collaborators":447,"id":451,"slug":452,"hasResults":453,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":453,"sex":459,"minAge":460,"maxAge":25,"enrollmentInfo":461,"targetDuration":25,"studyType":464,"phases":465,"briefSummary":467,"conditions":468,"keywords":474,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":487},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CardioGard Embolic Protection Cannula","ACTIVE_COMPARATOR","In patients assigned to the embolic protection device group, the CardioGard Embolic Protection Cannula is used instead, according to the manufacturer's instructions for use (IFU).",[13],"Device: CardioGard Embolic Protection Cannula",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Aortic Cannula","PLACEBO_COMPARATOR","In patients assigned to the standard cannula group, standard cannulation techniques are performed using any standard aortic cannula of the surgeon's choice",[19],"Device: Standard Aortic Cannula",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","The CardioGard embolic protection cannula is a device that combines the function of a standard aortic cannula with an added suction mechanism to capture debris that may result from cardiac surgery. The device is comprised of 2 hollow tubes. The first tube is the standard main forward-flow tube to return oxygenated blood to the patient's aorta. The second tube attached to an existing bypass vent port, is a novel element located posteriorly to the main tube; its function is to facilitate blood and particle suction by directing the blood back to the reservoir of the coronary bypass machine, while the retrieved embolic debris is eliminated through the filter of the venous reservoir.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"An aortic cannula is a device that is used routinely during cardiac surgery to return oxygenated blood from the cardiac bypass machine into the patient's aorta.",[15],[30,33,36],{"name":31,"affiliation":5,"role":32},"Annetine C. 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Pico","APICO@mgh.harvard.edu",{"name":196,"role":32,"phone":25,"phoneExt":25,"email":25},"Nathaniel Langer",{"facility":198,"status":48,"city":199,"state":200,"zip":201,"country":52,"countryCode":53,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"University of Michigan","Ann Arbor","Michigan","48109",{"type":55,"coordinates":203},[204,205],-83.74088,42.27756,{"lat":205,"lon":204},[208,211],{"name":209,"role":42,"phone":25,"phoneExt":25,"email":210},"China Green","chjgreen@med.umich.edu",{"name":212,"role":32,"phone":25,"phoneExt":25,"email":25},"Gorav Ailawadi",{"facility":214,"status":48,"city":215,"state":216,"zip":217,"country":52,"countryCode":53,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Mayo Clinic","Rochester","Minnesota","55905",{"type":55,"coordinates":219},[220,221],-92.4699,44.02163,{"lat":221,"lon":220},[224,227],{"name":225,"role":42,"phone":25,"phoneExt":25,"email":226},"Jennifer 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Lu","bl2699@cumc.columbia.edu",{"name":259,"role":32,"phone":25,"phoneExt":25,"email":25},"Isaac George",{"facility":261,"status":100,"city":247,"state":247,"zip":262,"country":52,"countryCode":53,"cosmosGeoPoint":263,"geoPoint":265,"contacts":25},"New York Presbyterian-Cornell Medical Center","10065",{"type":55,"coordinates":264},[251,252],{"lat":252,"lon":251},{"facility":267,"status":100,"city":247,"state":247,"zip":268,"country":52,"countryCode":53,"cosmosGeoPoint":269,"geoPoint":271,"contacts":25},"NYU Langone Hospital Brooklyn","11220",{"type":55,"coordinates":270},[251,252],{"lat":252,"lon":251},{"facility":38,"status":48,"city":247,"state":247,"zip":154,"country":52,"countryCode":53,"cosmosGeoPoint":273,"geoPoint":275,"contacts":276},{"type":55,"coordinates":274},[251,252],{"lat":252,"lon":251},[277,280],{"name":278,"role":42,"phone":25,"phoneExt":25,"email":279},"Kristine Gowan","KMcGowan@northwell.edu",{"name":281,"role":32,"phone":25,"phoneExt":25,"email":25},"Pey-Jen Yu",{"facility":283,"status":48,"city":284,"state":247,"zip":285,"country":52,"countryCode":53,"cosmosGeoPoint":286,"geoPoint":290,"contacts":291},"Montefiore Medical Center","The Bronx","10467",{"type":55,"coordinates":287},[288,289],-73.86641,40.84985,{"lat":289,"lon":288},[292,295],{"name":293,"role":42,"phone":25,"phoneExt":25,"email":294},"Agnieszka Siemienik","asiemien@montefiore.org",{"name":296,"role":32,"phone":25,"phoneExt":25,"email":25},"Daniel Goldstein",{"facility":298,"status":48,"city":299,"state":300,"zip":301,"country":52,"countryCode":53,"cosmosGeoPoint":302,"geoPoint":306,"contacts":307},"Duke University","Durham","North Carolina","27710",{"type":55,"coordinates":303},[304,305],-78.89862,35.99403,{"lat":305,"lon":304},[308,311],{"name":309,"role":42,"phone":25,"phoneExt":25,"email":310},"Mary Motta","mary.motta@duke.edu",{"name":312,"role":32,"phone":25,"phoneExt":25,"email":25},"Jeffrey 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Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":55,"coordinates":341},[342,343],-75.16362,39.95238,{"lat":343,"lon":342},[346,349],{"name":347,"role":42,"phone":25,"phoneExt":25,"email":348},"Mary L Mayer","marylou.mayer@uphs.upenn.edu",{"name":350,"role":32,"phone":25,"phoneExt":25,"email":25},"Michael Acker",{"facility":352,"status":353,"city":354,"state":355,"zip":356,"country":52,"countryCode":53,"cosmosGeoPoint":357,"geoPoint":361,"contacts":362},"University of Virginia","NOT_YET_RECRUITING","Charlottesville","Virginia","22903",{"type":55,"coordinates":358},[359,360],-78.47668,38.02931,{"lat":360,"lon":359},[363,366],{"name":364,"role":42,"phone":25,"phoneExt":25,"email":365},"Ashley Fox","ATF4C@uvahealth.org",{"name":367,"role":32,"phone":25,"phoneExt":25,"email":25},"John Kern",{"facility":369,"status":48,"city":370,"state":371,"zip":372,"country":52,"countryCode":53,"cosmosGeoPoint":373,"geoPoint":377,"contacts":378},"West Virginia University","Morgantown","West Virginia","26506",{"type":55,"coordinates":374},[375,376],-79.9559,39.62953,{"lat":376,"lon":375},[379,382],{"name":380,"role":42,"phone":25,"phoneExt":25,"email":381},"Misa Shaw","misa.shaw1@wvumedicine.org",{"name":383,"role":32,"phone":25,"phoneExt":25,"email":25},"James Mehaffey",{"facility":385,"status":48,"city":386,"state":387,"zip":25,"country":388,"countryCode":389,"cosmosGeoPoint":390,"geoPoint":394,"contacts":395},"London Health Sciences Centre","London","Ontario","Canada","CA",{"type":55,"coordinates":391},[392,393],-81.23304,42.98339,{"lat":393,"lon":392},[396,399],{"name":397,"role":42,"phone":25,"phoneExt":25,"email":398},"Stephanie Fox","Stephanie.Fox@lhsc.on.ca",{"name":400,"role":32,"phone":25,"phoneExt":25,"email":25},"Michael Chu",{"facility":402,"status":48,"city":403,"state":387,"zip":25,"country":388,"countryCode":389,"cosmosGeoPoint":404,"geoPoint":408,"contacts":409},"University of Ottawa Heart Institute","Ottawa",{"type":55,"coordinates":405},[406,407],-75.69812,45.41117,{"lat":407,"lon":406},[410,413],{"name":411,"role":42,"phone":25,"phoneExt":25,"email":412},"Nahya Awada","naawada@ottawaheart.ca",{"name":414,"role":32,"phone":25,"phoneExt":25,"email":25},"Pierre Voisine",{"facility":416,"status":353,"city":417,"state":418,"zip":25,"country":388,"countryCode":389,"cosmosGeoPoint":419,"geoPoint":423,"contacts":424},"Montreal Heart Institute","Montreal","Quebec",{"type":55,"coordinates":420},[421,422],-73.58781,45.50884,{"lat":422,"lon":421},[425,428],{"name":426,"role":42,"phone":25,"phoneExt":25,"email":427},"Alexandre Bergeron","Alexandre.Bergeron.icm@icm-mhi.org",{"name":429,"role":32,"phone":25,"phoneExt":25,"email":25},"Denis Bouchard",{"facility":431,"status":353,"city":432,"state":418,"zip":433,"country":388,"countryCode":389,"cosmosGeoPoint":434,"geoPoint":438,"contacts":439},"Hôpital Laval","Québec","QC G1V 4G5",{"type":55,"coordinates":435},[436,437],-71.21454,46.81228,{"lat":437,"lon":436},[440,443],{"name":441,"role":42,"phone":25,"phoneExt":25,"email":442},"Annie Bergeron","annie.bergeron@criucpq.ulaval.ca",{"name":414,"role":32,"phone":25,"phoneExt":25,"email":25},{"type":32,"investigatorFullName":445,"investigatorTitle":446,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Annetine Gelijns","Professor of Health Policy, Chair Department of Health Evidence & Policy",[448],{"name":449,"class":450},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100518226","ctsn-embolic-protection-trial-100518226",false,"NCT06027788","CTSN Embolic Protection Trial","Embolic Protection in Patients Undergoing High-Risk Valve Surgery","EMPRO","Inclusion Criteria:\n\n* Age ≥ 60 years\n* Planned de novo or redo:\n\n  * Surgical aortic valve replacement SAVR ± ascending aortic repair (if circulatory arrest is not required) ± CABG\n  * Mitral valve replacement (MVR) ± CABG\n  * Mitral Valve Repair + CABG,\n  * Double\u002FTriple valve surgery ± CABG; Ross procedure These procedures can be done via a full or minimal-access sternotomy (using central aortic perfusion cannulae) with legally marketed valve(s), and can be done in combination with an left atrial appendage (LAA) closure\u002Fexcision or partial\u002Fcomplete Maze procedure.\n  * Valve sparing aortic root replacement (David procedure)\n  * Valve sparing aortic root replacement (David procedure)\n* No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤2 within 30 days prior to randomization\n* Ability to provide informed consent and comply with the protocol\n\nExclusion Criteria:\n\n* History of clinical stroke within 3 months prior to randomization\n* Cerebral and or aortic arch arteriography or interventions within 3 days of the planned procedure\n* Coronary catheterization within 3 days of index procedure, and the required repeat NIHSS score post-catheterization is worse than the screening\u002Fbaseline NIHSS score conducted prior to the catheterization\n* Active endocarditis at time of randomization with vegetation criteria\n* Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization\n* Participation in an interventional (drug or device) trial\n* Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve repair and tricuspid valve repair\n* Anticipated requirement for prolonged mechanical ventilation greater than 48 hours after surgery in the opinion of the investigator\n* Planned concomitant carotid endarterectomy during index surgical procedure","ALL","60 Years",{"count":462,"type":463},842,"ESTIMATED","INTERVENTIONAL",[466],"NA","This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.",[469,470,471,472,473],"Delirium","Ischemic Stroke","Acute Kidney Injury","Heart Valve Disease","Coronary Artery Disease",[475,476,477],"Embolic Protection","Cardiac Surgery","CardioGard","2026-05-26",{"date":480,"type":481},"2026-05-29","ACTUAL",{"date":483,"type":481},"2023-09-18",{"date":485,"type":463},"2027-04-01",{"name":5,"class":6},28]